The concept of "enhanced recovery after surgery" has become increasingly popular in elective abdominal surgeries. Yet, the role of this concept has not been described in emergency procedures. Therefore, this study aimed to investigate the feasibility of fast-track surgery in patients with perforated peptic ulcer.

The patients who will have a conventional surgical treatment will be included.

Procedure: Surgical repair of perforated peptic ulcer

Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.

Active Comparator: Fast-track surgery

The patients who will have fast-track surgery will be included.

Procedure: Surgical repair of perforated peptic ulcer

Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.

Detailed Description:

The study is designed as a randomized, controlled clinical study. The patients with a preoperative diagnosis of perforated peptic ulcer will be recruited for the study. Among those, the patients with a definitive diagnosis of perforated peptic ulcer confirmed by surgical exploration will be included.

The patients will be randomized according to their protocol number given automatically by the registration system of the hospital during admission. The patients who have an odd protocol number will have conventional surgical protocol, and those who have an even protocol number will have fast-track surgery protocol.

The conventional surgical protocol for perforated peptic ulcers is composed of regular general anesthesia, postoperative pain control by intravenous analgesics, removal of nasogastric tube by the end of 48th postoperative hour, initiation of oral intake after clinical signs of active bowel movement is observed. Fast-track surgery protocol, however, is composed of general anesthesia with short-acting agents and the use of regional anesthesia if possible, removal of nasogastric tube during recovery from anesthesia, aggressive pain control, initiation of oral intake by the end of 48th postoperative hour.

All of the patients will be scheduled for control gastroscopy in the end of six weeks after surgery.

Primary end-point is the morbidity and mortality rate. Secondary end-points are length of hospital stay, readmission rate, endoscopic findings in control gastroscopy.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Perforated peptic ulcer located in the stomach or the duodenum

Exclusion Criteria:

The patients who refuse to join the study or to sign the informed consent form

The patients who are unable to understand and sign the informed consent form

Age younger than 18

The patients with a possibility of having trouble in communicating with or reaching the investigators during the first 6 weeks after surgery

The patients who are considered as ASA class 4

Shock on admission

The patients who have serious negative factors for wound healing such as steroid usage, autoimmune diseases

Pregnant

Previous upper abdominal surgery

The patients who are found to have a pathology other than perforated peptic ulcer during surgical exploration

The patients who are found to have malignant ulcer during surgery or in postoperative period

Concomitant bleeding peptic ulcers

Peptic ulcer perforations with a diameter greater than 5 mm, which are not suitable for simple repair techniques

Multiple perforated peptic ulcers

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620671